Regulatory Diagnostics Manager

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Summary

The Regulatory Diagnostics Manager (RDM) for Precision Diagnostics is responsible for the implementation of strategic plans for diagnostics development, including companion diagnostics, related to Novartis\’s innovative medicines portfolio, including marketed products. The RDM collaborates with senior members of the RA Precision Diagnostics Team, including the TA and Diagnostics Lead, on strategies and submissions such as companion diagnostics. They work closely with internal RA Disease Unit associates, Digital, Data and Clinical Innovation (DDCI) at Novartis, and Partner Companies developing diagnostics, ensuring compliance with regulatory requirements. The RDM also provides regulatory support, including tactical and technical direction for clinical trial assays, to ensure regulatory compliance.

About The Role

Job Description

Major Accountabilities

Regulatory Strategy and Implementation

• Supports diagnostics regulatory strategy for precision IVDs and CDx (e.g., US, EU, Japan, China).
• Responsible for submissions in premarket and post-market spaces, including IDE, Significant Risk Determinations, PsA, and pre-market authorization, with support from the RA TA and Diagnostics Lead.
• Ensures diagnostic regulatory input is incorporated into drug development strategies, meeting IVD, CDx, and LDT regulations.
• Partners with RA country organizations to align on local regulatory requirements and deliver timely submissions.
• Prepares, files, and coordinates briefing books for HA meetings related to diagnostics and CDx development.
• Develops and manages plans for responses to HA requests and follow-up activities.
• Participates as a member of RA subteam and BDST as appropriate.

Training and Compliance

Supports compliance activities for clinical trials related to global regulations on diagnostics, ensuring regulatory compliance of Partner companies, and supports roll-out of new procedures and training.

Performance Indicators

• Successful implementation of regulatory strategies with timely submissions.
• Full compliance with IVD and LDT rules.
• Identification of diagnostic needs for Novartis programs.
• Strong partnership with RA Diagnostics Team and community adherence to policies.

Experiences & Skills

• Minimum 2-4 years of experience in diagnostics, IVD, or CDx development within the pharmaceutical industry.
• Science-based BS or MS; advanced degrees preferred.
• Proven experience in regulatory projects/submissions involving IVD/CDx.
• Understanding of IDE, MAA, NDA/BLA, 510(k), PMA submissions.
• Knowledge of assay validation and CLIA.
• Understanding of clinical trials.
• Strong interpersonal and negotiation skills.

Why Novartis

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